Cervical biopsy-sampling instrument

ABSTRACT

A cervical biopsy-sampling instrument is disclosed which comprises an aspirator having a spatulated sampling tip thereon by which a mucus aspirate and surface scrapings are collected from the cervix for cytological diagnosis. The tip is flexibly connected with the aspirator so that it can follow the relative deflection of the cervical canal when the canal is out of alignment with the vaginal canal. In addition, the scraping edge of the tip is defined on at least one side by a profile face of the tip which is substantially flat over the entire profile on that side, so that the edge and face of the tip can be applied to a smear plate in the manner of a spatula for purposes of transferring the scrapings directly to the plate from the tip.

United States Patent [72] lnventor Gerald C. Kohl 1106 S. 4th Street,Tacoma, Wash. 98405 [21] Appl. No. 709,470 [22] Filed Feb. 29, 1968 [45]Patented Jan. 12, 1971 [54] CERVICAL BIOPSY-SAMPLING INSTRUMENT 6Claims, 4 Drawing Figs.

[52] US. Cl 128/2, 128/278,128/304 [51] Int. Cl A6lb 10/00 [50] FieldofSearch... 128/2, 28, 304, 303, 276, 278

[56] References Cited UNITED STATES PATENTS 2,471,088 5/1949 Ayre 128/23,088,454 5/1963 Shute 128/2 3,315,661 4/1967 Groat., 128/2 3,352,29911/1967 Sagiroglu 128/2 4/1969 Kariher et a]. 128/2 FOREIGN PATENTS1,324,126 3/1963 France 128/2 Primary Examiner-Richard A. GaudetAssistant Examiner-Kyle L. Howell Attorney-Christensen, Sanborn &Matthews ABSTRACT: A cervical biopsy-sampling instrument is dis-. closedwhich comprises an aspirator having a spatulated sampling tip thereon bywhich a mucus aspirate and surface scrapings are collected from thecervix for cytological diagnosis. The tip is flexibly connected with theaspirator so that it can follow the relative deflection of the cervicalcanal when the canal is out of alignment with the vaginal canal. Inaddition, the scraping edge of the tip is defined on at least one sideby a profile face of the tip which is substantially flat over the entireprofile on that side, so that the edge and face of the tip can beapplied to a smear plate in the manner of a spatula for purposes oftransferring the scrapings directly to the plate' from the tip.

CERVICAL BIOPSY-SAMPLINGINS'IRUMENT FIELD Ol-Tl-IE INVENTION Thisinvention relates to medical sampling instruments, and more particularlyto medical sampling instruments for collecting tissue cell specimensfrom the female cervix for cytological diagnosis. I

BACKGROUND OF TI-IE'INVENTION INCLUDING CERTAIN OBJECTS THEREOF Incollecting specimens of this nature .in the past, scrapers have beenused to collect cells from the surfaces of the endocervical canal andthe portio vaginalis. In addition, aspirator pipettes have been used tocollect a mucus specimen from the internal os of the cervix on thetheory that the combined specimens allow for a more comprehensivediagnosis; In recent years, moreover, instruments have been proposedwherein a scraper edge is combined with an aspirator pipette to enablethe two specimensto be taken simultaneously. Unfortunately, however,these dual-purpose instruments have not been commercially acceptable inthat they require an additionalinstrument such as' aspatula, with whichto transfer the collected scrapings to a smear plate. They also lack theflexibility necessary to execute the sampling'operation withoutdiscomfort to the'patie'nt and without abrading the surfaces of thecervix to the extent that the specimen is spoiled by an excessiveblood'accumulatio'n. In fact, the task of executing the samplingoperation with one of these dual-purpose instruments, and thentransferring the specimen to the smear plate, has proven to be sodelicate and time consuming a procedure that until the time of thepresent invention the art had continued to use the single purposescraping and'pipette devices known theretofor; 1 I Y i V One object ofthe present invention, therefore, is to devise a dual-purpose instrumentof this nature which is capable of collecting both mucus and scrapingsin the manner of the earlier instruments, but which is free from thedrawbacks which characterized these earlierinstrumentsas mentionedabove. Another object is to devise an instrument of this nature which isequipped with a sampling tip that operates not only as a means ofgathering scrapings and mucus in the manner described, butalso as'ameans of applying and spreading the collected material over thesurface-of a smear plate, so as to eliminate the necessity for anadditional instrument and an intermediate transfer step. A third objectis to provide aninstrument of this nature which is equipped with asampling tip that is capable of limited transverse flexure in relationto the aspirator so as to follow the relative deflection of the cervicalcanal when it is not aligned with the vaginal canal. A still furtherobject is to provide an instrument of this nature in which the samplingtip is also capable of limited axial flexure in relation to theaspirator so as to cushion the initial impact of the tip on the cervixand the subsequent application of it to the cervix as a scraper. Otherobjects include the provision of an instrument of this nature which isinexpensive to manufacture and in fact so inexpensive as to hedisposable after each operation; and which is capable of collecting thespecimen without discomfort and trauma to the patient and withoutcontaminating or otherwise spoiling the reliability'of the specimen.Still further objects will appear from the'description of the inventionwhich follows hereafter.

. SUMMARY or THE INVENTION These objects and advantages are realized bya cervical biopsy-sampling instrument of my inventionwhich comprises anaspirator tube having a plunger therein, and a spatulated sampling tipformed on the distal end thereof to serve both as the means ofcollecting the specimen or specimens, and as the means of applying themto one or more smear plates. The tip is flexibly connected with thedistal end of the tube, and has a relatively forward edge thereon whichis relatively transversely disposed to the tube and operates as thescraping edge for the instrument. An elongated pipette extends throughthe scraping edge from a point of communication with the tube, andprojects relatively forwardly from the edge for insertion in thecervical canal. When insened,,the pipette serves as a means of gatheringa mucus specimen from the internal os of the cervix, and also as a pivotabout which the scraping edge is applied to the portio vaginalis.Preferably, the tip is capable of both limited transverse and limitedaxial flexure with respect to the tube. I also prefer to form the tip sothat the scraping edge is defined on at least one side by aprofile faceof the tip which is substantially parallel to the pipette andsubstantially flat over the entire profile of the tip on that side. Inthis way, the edge and face of the tip can be applied to the smear platein the manner of a spatula for purposes of transferring the scrapings tothe plate from the tip. The edge and face of the tip can also beemployed to spread-the scrapings over the surface of the plate. Themucus specimen collected through the pipette may be applied to the sameplate with the scrapings or to a separate plate. In either case theaforesaid edge and face of the tip can also be employed to spread themucus specimen over the surface of its plate in thesame manner as withthe scrapings.

The presently preferred embodiments of my invention employ a tip whichhas a smoothly curved indentation in the scraping edge thereof. Theindentation is disposed adjacent to the pipette and conforms to therounded contour of the portio vaginalis. The valley of the indentationis interconnected with the forwardly projecting portion of the-pipetteby means of a smoothly curved fillet which projects to a slight extentinto the endocervical canal with the pipette These embodiments alsoemploy a flexible sleeve as the means of interconnecting 'the tip withthe distal end of the 'tube. The sleeve is corrugated so as to allow forboth limited transverse and limited axial movement of the tip inrelation to the tube. This universal movement enables the instrument toadapt to the relativedeflection of the vaginal and cervical canals inthose cases where the cervix is anteriorly or posteriorly flexed, orretroverted in relation to the vagina.

These features will be better understood by reference to theaccompanying drawing wherein l have illustrated one of the preferredembodiments.

BRIEF DESCRIPTION OF THE DRAWING relative deflection of the vaginal andcervical canals; and

FIG. 4 is a part perspective view of the embodiment and particularly thetip as it is applied to the surface of a smear I I I plate for purposesof transferring the scrapings thereto.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring firstly to FIG. I itwill be seen that the illustrated embodiment comprises an aspirator tube2 which has a plunger 4 therein to enable a suction head to be generatedat the left-hand or distal end 6 of the tube. The tube is preferablymolded from a plastic resin, and in the molding process an annularflange 8 is formed on the right-hand or proximal end 10 of the tube toprovide an enlarged surface 12 which can be easily gripped for rotationof the tube. Knurling or serrations on the peripheral surface 12 of theflange aid in gripping it for this purpose. The plunger 4 is essentiallya small rubber piston 14 which is slidably received in the bore 16 ofthe tube to be 20. The cylinder has a smaller diameter than the flange 8of the tube, but is slightly greater in diameter than the bore 16 of thetube so as to form a limit stop for the advance of the piston 14. Asseen in the FIGS. the piston can advance only to a point short of thedistal end 6 of the tube.

In molding the tube a flexible sleeve 22 is formed on the distal endthereof which is corrugated so that it can be flexed in both thetransverse and axial senses with respect to the tube. However, thecorrugations 24 terminate short of the sleeves own distal end 26 so asto allow for a smooth cylindrical neck 28 thereon; and molded integrallywith the neck is a spatulated sampling tip 30 having the characteristicsmentioned hereinabove under the summary of the invention. The tipcomprises a flat generally heart-shaped spatula 32 which has a thicknessof less than the diameter of the sleeve 22, and an elongated pipette 34passing therethrough from the neck 28 of the sleeve. The opposingheart-shaped faces 36 of the spatula are substantially parallel to thepipette, and are substantially flat across the entire profile of thespatula on each side.

The pipette 34 projects relatively forwardly from the spatula 32 andbisects the spatula into upper and lower lobes, 38 and 40 respectively,as it is seen in FIG. 1. The upper lobe 38 is somewhat larger than thelower lobe 40, and is also somewhat forwardly displaced in relation toit, as is better seen in FIGS. 2 and 3. In addition, the relativelyforward edge 42 of the upper lobe has a smoothly curved indentation 44therein which conforms to the contour of the portio vaginalis. Thevalley of the indentation is interconnected with the projecting portionof the pipette by a smoothly curved fillet 46 which terminates somewhatforwardly from the edge 42. The forward edge 48 of the lower lobe isalso interconnected with the projecting portion ofthe pipette by asimilar fillet 50.

During the sampling operation, a speculum is used to assist in insertingand applying the tip of the instrument. The speculum is used firstly todilate the vaginal canal, and while it is thus employed, the physicianinserts the projecting portion of the pipette 34 in the endocervicalcanal of the patient and abuts the valley of the indentation 44 againstthe surface of the portio vaginalis. Then, while gripping the flangedproximal end 8 of the aspirator tube 2 in one hand and the cylinder 20of the plunger 4 in the other, he proceeds to collect a mucus aspiratefrom the internalos of the cervix, and tissue cell scrapings from thesurface of the portio vaginalis. The mucus specimen is collected byretracting the plunger 4 from the tube 2; whereas the scrapings arecollected by rotating the tube so as to skim the surface of the portiovaginalis with the forward edge 42 of the upper lobe 38 of the spatula.The lower lobe 40 acts as ballast to the upper lobe, and the fillets 46and 50 serve to spread the small opening through which the pipetteenters the endocervical canal. The fillet 46 of the upper lobe alsocollects scrapings from the mouth of the canal, and operates as a wedgeto force the portio vaginalis into the valley of the indentation 44 asthe instrument is rotated.

After the instrument has been withdrawn from the patient, the mucusaspirate collected in the tube 2, and the scrapings collected on theforward edge of the spatula 32 are directly applied to he surface of asmear plate or plates. In the case of the scrapings, the instrument ispositioned over a narrow rectangular smear plate such as that seen at 52in FIG. 4, and the spatula 32 is applied in short strokes over thesurface of the plate until the scrapings are displaced from the edge 42onto the plate. The sleeve 22 is sufficiently offset to the rear of thespatula and sufficiently limited in flexure that it does not interferewith the application procedure, nor the subsequent task of spreading thespecimen over the surface of the plate 52 with the spatula. The mucusaspirate can be smeared over the plate with the scrapings or it can beapplied to a separate plate as indicated earlier.

In those cases where the cervix is nonaligned with the vaginal canal asin FIG. 3, the limited flexure in the sleeve 22 enables the tip 30 toflcx both transversely and axially in relation to the tube. Thus, thecurvature and flexure in the wall of the vaginal canal do not causediscomfort to the patient, nor

hamper the sampling procedure from the physicians standpoint.

The instrument is normally packaged in a sterile condition, and is massproduced for a price in the order of 10 cents per unit, so as to make ita commercially disposable item.

If desired, the pipette may be lengthened or shortened to sample theuterine cavity or the external 05. In addition, many other changes and-additions can be made in and to the described instrument withoutdeparting from the scope and spirit ofthe invention as defined in thefollowing claims.

I claim:

1. A cervical biopsy-sampling instrument comprising an aspirator tubehaving a plunger therein which is equipped with means that extend fromthe proximal end of the tube for reciprocating the plunger within thetube, a sampling tip which is disposed at a location spaced relativelyforwardly from the distal end of the aspirator tube, and which includesa pipette that is adapted to be inserted into the endocervical canal,and has a laterally projecting lobe thereon, the relatively forward edgeof which lobe is adapted for scraping the portio vaginalis when thepipette is inserted into the endocervical canal, and the profile face ofwhich on one side thereof is adapted to be used as a spatula inspreading the scrapings on a smear plate, and means interposed betweenthe tip and the distal end of the tube which define a flexible jointwhereby the tip can flex in relation to the tube, there being a passagethrough the joint to provide intercommunication between the pipette andthe tube for withdrawing a sample of mucous from the canal into thepipette with the tube.

2. The cervical biopsy-sampling instrument according to claim 1 whereinthe flexible joint includes a flexible sleeve which is interposedbetween the tip and the distal end of the tube.

3. The cervical biopsy-sampling instrument according to claim 2 whereinthe sleeve is corrugated to allow for both limited transverse andlimited axial movement of the tip in relation to the tube.

4. The cervical biopsy-sampling instrument according to claim 1 whereinthe face of the lobe is substantially parallel to the pipette andsubstantially flat over the entire profile of the lobe on that side.

5. The cervical biopsy-sampling instrument according to claim 1 whereinthe relatively forward scraping edge of the lobe has a smoothly curvedindentation therein, the valley of which is interconnected with thepipette by a smoothly curved flllet which is adapted to project into theendocervical canal with the pipette 6. The cervical biopsy-samplinginstrument according to claim 1 wherein the sampling tip comprises aflat generally heart-shaped spatula which is bisected by the pipetteinto laterally opposing lobes having coplanar faces thereon which aresubstantially parallel to the pipette and substantially flat across theentire profile of the spatula on each side.

D STATES PATENT OFFICE PO70? U1 up 5 as,

CERTLTLCATE OF CORRECTIQN Patent No. 3 554 1.85 Dat d March 2 1971 lnGerald C. It is certified that error appears in the above-identifiedpatent and that said Letters Patent are hereby corrected as shown below:

Drawing sheets 1 and 2 of U. S. Patent No. 3 ,554 ,l8 6

are deleted.

Signed and sealed this 7th day of March 1972.

(SEAL) Afitest:

EDWARD M.FLETCHER,JR. ROBERT GOT'ISCHALK Attesting Officer Commissionerof Patents

1. A cervical biopsy-sampling instrument comprising an aspirator tubehaving a plunger therein which is equipped with means that extend fromthe proximal end of the tube for reciprocating the plunger within thetube, a sampling tip which is disposed at a location spaced relativelyforwardly from the distal end of the aspirator tube, and which includesa pipette that is adapted to be inserted into the endocervical canal,and has a laterally projecting lobe thereon, the relatively forward edgeof which lobe is adapted for scraping the portio vaginalis when thepipette is inserted into the endocervical canal, and the profile face ofwhich on one side thereof is adapted to be used as a spatula inspreading the scrapings on a smear plate, and means interposed betweenthe tip and the distal end of the tube which define a flexible jointwhereby the tip can flex in relation to the tube, there being a passagethrough the joint to provide intercommunication between the pipette andthe tube for withdrawing a sample of mucous from the canal into thepipette with the tube.
 2. The cervical biopsy-sampling instrumentaccording to claim 1 wherein the flexible joint includes a flexiblesleeve which is interposed between the tip and the distal end of thetube.
 3. The cervical biopsy-sampling instrument according to claim 2wherein the sleeve is corrugated to allow for both limited transverseand limited axial movement of the tip in relation to the tube.
 4. Thecervical biopsy-sampling instrument according to claim 1 wherein theface of the lobe is substantially parallel to the pipette andsubstantially flat over the entirE profile of the lobe on that side. 5.The cervical biopsy-sampling instrument according to claim 1 wherein therelatively forward scraping edge of the lobe has a smoothly curvedindentation therein, the valley of which is interconnected with thepipette by a smoothly curved fillet which is adapted to project into theendocervical canal with the pipette
 6. The cervical biopsy-samplinginstrument according to claim 1 wherein the sampling tip comprises aflat generally heart-shaped spatula which is bisected by the pipetteinto laterally opposing lobes having coplanar faces thereon which aresubstantially parallel to the pipette and substantially flat across theentire profile of the spatula on each side.